Retrieval of Patient Information After Discontinuation | NCT01658722

Studies
Retrieval of Patient Information After Discontinuation

NCT01658722

Sponsor

JANSSEN Alzheimer Immunotherapy Research & Development, LLC

Status

Terminated

Last Update Posted

Sep 2, 2015Estimated

Enrollment

169Actual

Phase

Not provided

Conditions

Alzheimer's Disease

Interventions

Bapineuzumab

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Mar 12, 2012

First Submission Date that Met QC Criteria

Aug 2, 2012

First Posted Date

Aug 7, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2015

Last Update Posted Date

Sep 2, 2015Estimated

Name	Class
Pfizer	INDUSTRY

Description Module

Brief Summary

A Phase 3b, Study of Subjects With Alzheimer's Disease Who Discontinued Treatment in Bapineuzumab Phase 3 Clinical Studies (ELN115727-301/302/351) or Who Completed Studies ELN115727-301 and 302 but did not Enroll in Study ELN115727-351.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

169Actual

Label	Type	Description	Intervention Names
Observational		Long term follow-up	Drug: Bapineuzumab

Name	Type	Description	Arm Group Labels	Other Names
Bapineuzumab	Drug		Observational

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dependence Scale	Caregiver's assessment of a patient's need for assistance	4 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Signed, dated, and written informed consent obtained from the subject and/or the subject's legally acceptable representative (LAR, if applicable) in accordance with local regulations.
Signed, dated, and written informed consent, obtained from the subject's caregiver in accordance with local regulations.
Subject must have participated in the Study 301, 302, or 351 and have received at least 1 dose of study treatment (bapineuzumab or placebo).
Subject must have been off treatment for at least 12 months prior to Visit 1.
Subjects must have a primary caregiver for the duration of the study.
Subject's caregiver must have the ability to assess the subject and answer questions over the phone.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects with Alzheimer's disease who discontinued treatment in bapineuzumab Phase 3 clinical studies (ELN115727-301/302/351) or who completed studies ELN115727-301 or 302 but did not enroll in study ELN115727-351

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C545458	bapineuzumab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided